Schumer urging on FDA for stricter painkiller regulations

March 16, 2013

The use of pain killers containing hydrocodone as an abused prescription drug is becoming more common and Sen. Charles Schumer is urging stricter regulations on the prescription.

Schumer is calling on the Federal Food and Drug Administration to approve stricter regulations to make it harder for patients to access medicine containing hydrocodone. The Drug Safety and Risk Management Advisory Committee met recently and recommended hydrocodone be classified as a Schedule II controlled substance. While Schumer does respect patients do use the drug for legitimate uses - hydro-codone is one of the most prescribed painkillers with more than 40 million Americans using the prescription in 2011, he is worried about patients who abuse the drug. The drug was used in more than 14,800 overdose cases in 2008, according to the CDC. That number is more than heroin and cocaine combined.

In 2011, the Upstate New York Poison Control Center reported over 12,000 cases of prescription drug abuse. In Western New York, there were over 2,300 cases; 187 cases of abuse in Cattaraugus County; 379 in Chautauqua County; and 1,340 in Erie County. One in 20 people misused prescription pain killers in 2010, according to the Center for Disease Control.

"Each day that passes means rising abuse, and even death, at the hands of hydrocodone-based drugs," Schumer said. "With a key hurdle recently cleared, the FDA must tighten up control of one of the most highly prescribed and abused drugs on the Upstate New York market."

The Drug Safety and Risk Management Advisory Committee met in late January to discuss the reclassification of hydrocodone. Their recommendation was to increase the drug's classification from Schedule III to Schedule II by a vote of 19-10. Drugs classified in Schedule II are narcotics, such as oxycodone and morphine, and stimulants, such as methamphetamine and amphetamine. Schedule II controlled substances require stricter regulations at pharmacies. All prescriptions must be written or electronically filled and must be signed by the doctor. Every time the prescription must be filled, a new prescription must be issued each time. If multiple prescriptions for Schedule II are given to a patient, a doctor may write a 90-day supply provided several conditions - a legitimate medical purpose for each prescription with written instructions on each prescription. All drugs must be permissible under state law and the risk of abuse is not created with each different drug.

"The federal government must do everything in its power to restrict the use of hydrocodone to those patients who actually need it, and I'm urging the Food and Drug Administration to support its drug safety panel's recommendation to reclassify hydrocodone as a Schedule II drug, to help end this scourge that has caused our country to see more overdose deaths from this drug than seen with heroin and cocaine combined," Schumer said. "Stricter federal rules must be put in place regarding the regularity and quantity with which we prescribe these painkillers, so that our children, parents, spouses and friends don't continue to fall prey to them each day."

FDA Commissioner Margaret Hamburg must approve these recommendations. Once approved, they will be sent to the Department of Health and Human Services for a positive recommendation to the Drug Enforcement Administration. Schumer noted the FDA is the biggest hurdle, seeing as the DEA already wants the reclassification. The FDA has declined the categorical change in the past. In December, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted down a recommendation to allow a pure hydrocodone product to be prescribed. Schumer worked closely with the FDA in January 2012 to urge the denial of the proposal.